We connect the dots –
so you can focus on your business.

We focus our efforts on supporting clients who either lack resources familiar with medical device development or wish to complement their existing resources.

Too much on your plate? Get in touch!


Effective project management throughout the entire product lifecycle: keeping projects in time, on budget, and in compliance with ISO 13485 and 21 CFR 820

Combination Products
Medical Devices
In vitro Diagnostics
In Use


  • Structured user centered concept development
  • Innovative requirements management - reduced burden of documentation and improved traceability
  • Patient preference studies
  • Partner network for industrial design, mechanical design, hardware and software design
  • Supplier evaluation and audits
Design Control
  • Establishment of EU and US compliant development processes and documentation
Risk Management
  • Implementation of risk management processes according to ISO 14971
  • Moderation of risk management meetings
Human Factors
  • Usability engineering and local support for US or EU handling studies
Clinical Development
  • Creation of clinical evaluation according to MEDDEV. 2.7.1 by qualified individuals
  • Identification and analysis of relevant clinical data
  • Clinical Investigations

Meet the team

Dr. Dirk Kreder Founder and CEO
Dipl.-Ing. Michael Gschwandtner Co-Founder and CTO
Dr. Peter Müller Senior Device Development Manager
Johann Delchmann, B.Eng. Medical Device Specialist
Dr. Bernd Krämer Senior Director IVD
Dipl.-Ing. (FH) Andreas Harnisch Senior Device Development Manager

Read more about us

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